PRODUCT DETAIL

Imipenem/Cilastatin Noridem 500 mg/500 mg prášok na infúzny roztok

Code

2095F

MA number

15/0425/25-S

Product Form:

plv ifo 25x500 mg/500 mg (liek.inj.skl.)

MA Status:

R - Valid Marketing Authorisation

Type of procedure:

Mutual recognition procedure

MAH, country:

Noridem Enterprises Ltd., Cyprus

Therapeutic Class:

15 - ANTIBIOTICA (PROTI MIKROB. A VÍRUSOVÝM INFEKCIAM)

ATC:

J	ANTIINFECTIVES FOR SYSTEMIC USE
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01DH	Carbapenems
J01DH51	Imipenem and enzyme inhibitor

Shelf life:

Container:

glass vial

Route of admin.:

Intravenous use

Prescription Status:	Medicinal product subject to medical prescription.
Legal basis:	Article 10(1) generic application
MA issued:	09.12.2025
Validity:	09.12.2030
Pediatric indication:	Yes
Pediatric posology:	Yes
Pediatric warnings:	Yes
PIL:	PIL_Imipenem_Cilastatin Noridem 500 mg_500 mg prášok na infúzny roztok_12_2025.pdf
SPC:	SPC_Imipenem_Cilastatin Noridem 500 mg_500 mg prášok na infúzny roztok_12_2025.pdf
Safety feature	Yes
Data update:	12.12.2025